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Different Versions of BCG with or without Vaccine Therapy in Treating Patients with High Grade Bladder Cancer That Is Not Muscle Invasive

Trial Status: Active

This randomized phase III trial studies bacillus Calmette-Guerin (BCG) Tokyo-172 strain solution with or without a vaccination, BCG Tokyo-172 strain vaccine, to see how well it works compared with BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. BCG is used in a solution to stimulate the immune system in the treatment of bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.

Inclusion Criteria

  • Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days prior to registration
  • Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration
  • Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (magnetic resonance imaging [MRI] or computed tomography [CT] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =< T1 disease within 90 days prior to registration
  • Patients must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification
  • Patients must not have pure squamous cell carcinoma or adenocarcinoma
  • Patients’ disease must not have micropapillary components
  • Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms
  • No other prior non-bladder malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible
  • Patients must have a Zubrod performance status of 0-2
  • Patients must not have received prior intravesical BCG or intradermal BCG
  • Patients must not be taking oral glucocorticoids at the time of registration
  • Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study
  • Patients must not have known history of tuberculosis
  • Patients must be negative for prior Tuberculosis infection as determined by a negative PPD test; if PPD is not available, then a negative interferon gamma release assay (IGRA) may be used; the PPD or IGRA test results must be obtained within 90 days prior to registration; PPD negativity is defined as < 10 mm diameter induration (palpable, raised hardened area) in the volar forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1 ml); for PPD readings done outside of 48-72 hour window, patients must have PPD test and reading repeated to confirm eligibility; IGRA positive is defined by the laboratory interpretation or using the package insert cut-off values; any IGRA approved by the Food and Drug Administration (FDA) is allowed, including the QuantiFERON–TB Gold In-Tube test (QFT–GIT) or the T–SPOT TB test (T–Spot)
  • Patients must be >= 18 years of age
  • Prestudy history and physical must be obtained within 90 days prior to registration; patients must have a complete blood count (CBC) and basic metabolic panel including creatinine, potassium, chloride, blood urea nitrogen (BUN), carbon dioxide (CO2) and glucose within 28 days prior to registration
  • Patients must not be pregnant or nursing as the use of intravesical BCG is not recommended during pregnancy; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must be offered the opportunity to participate in specimen banking for future studies to include translational medicine studies
  • Patients who can complete patient-reported outcome (PRO) forms in English or Spanish must complete the baseline Bladder Cancer Index, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C) 30, American Urological Association Symptom Score (AUASS), and Cancer Patient Tobacco Use Questionnaire forms

Alabama

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Caldwell
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Fruitland
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Meridian
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Nampa
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Louisiana

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New Orleans
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Ochsner Medical Center Jefferson
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University Medical Center New Orleans
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Shreveport
LSU Health Sciences Center at Shreveport
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Maryland

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Michigan

Ann Arbor
Saint Joseph Mercy Hospital
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Phone: 734-712-3671
University of Michigan Comprehensive Cancer Center
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Brownstown
Henry Ford Cancer Institute-Downriver
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Clinton Township
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Dearborn
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Detroit
Henry Ford Hospital
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Lansing
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Novi
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Warren
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West Bloomfield
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Missouri

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Montana

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Las Vegas Urology - Green Valley
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Las Vegas Urology - Pebble
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Las Vegas
Comprehensive Cancer Centers of Nevada
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Las Vegas Prostate Cancer Center
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Radiation Oncology Centers of Nevada Central
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New Jersey

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New York

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Roswell Park Cancer Institute
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Elmira
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New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Memorial Sloan Kettering Cancer Center
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Rochester
University of Rochester
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Syracuse
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North Carolina

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Ohio

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Kettering Medical Center
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Oklahoma

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Oregon

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Bay Area Hospital
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Portland
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Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
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Phone: 215-955-6084

South Carolina

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Phone: 843-789-7020
Clinton
Prisma Health Cancer Institute - Laurens
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Phone: 864-522-2066
Easley
Prisma Health Cancer Institute - Easley
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Phone: 864-522-2066
Greenville
Prisma Health Cancer Institute - Butternut
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Phone: 864-522-2066
Prisma Health Cancer Institute - Eastside
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Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
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Prisma Health Greenville Memorial Hospital
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Greer
Prisma Health Cancer Institute - Greer
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Seneca
Prisma Health Cancer Institute - Seneca
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Phone: 864-522-2066
Spartanburg
Prisma Health Cancer Institute - Spartanburg
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Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
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Phone: 214-648-7097
Galveston
University of Texas Medical Branch
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Phone: 409-772-1950
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
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Phone: 713-798-1354
Houston Methodist Hospital
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M D Anderson Cancer Center
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League City
UTMB Cancer Center at Victory Lakes
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San Antonio
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University Hospital
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Utah

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Phone: 888-424-2100
Salt Lake City
Huntsman Cancer Institute / University of Utah
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Washington

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West Virginia

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Wisconsin

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Milwaukee
Medical College of Wisconsin
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Minocqua
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Rice Lake
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Stevens Point
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Wausau
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Weston
Marshfield Clinic - Weston Center
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Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
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PRIMARY OBJECTIVES:

I. To compare whether time to high-grade recurrence (TTHGR) for patients with BCG-naive, non-muscle invasive bladder cancer (NMIBC) receiving BCG Tokyo-172 strain solution (Tokyo-172 BCG) (Arm II) is non-inferior to patients receiving BCG solution (BCG LIVE [TICE BCG]) (Arm I).

II. To test whether TTHGR for patients with BCG-naive, NMIBC receiving intradermal BCG Tokyo-172 strain vaccine (Tokyo-172 BCG vaccination) followed by intravesical Tokyo-172 BCG instillation (Arm III) is superior to patients receiving intravesical Tokyo-172 BCG instillation without prior intradermal BCG vaccination (Arm II).

SECONDARY OBJECTIVES:

I. To compare time to recurrence (TTR) with any-grade (AG) bladder cancer between:

Ia. patients receiving Tokyo-172 versus BCG LIVE (TICE BCG) strain.

Ia. Patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.

II. To compare progression-free survival (PFS) between:

IIa. Patients receiving Tokyo-172 versus BCG LIVE (TICE BCG) strain.

IIa. Patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.

III. To estimate the complete response (CR) rate for carcinoma in situ (CIS) patients at 6 months in patients receiving intravesical versus intravesical only Tokyo-172 BCG (Arms II & III will be evaluated separately).

IV. To evaluate the duration of CR by treatment arm for patients with CIS who have a CR at 6 months.

V. To test whether TTHGR for patients with BCG-naive, NMIBC receiving intradermal Tokyo-172 BCG vaccination followed by intravesical Tokyo-172 BCG instillation is superior to patients receiving intravesical TICE BCG strain.

PRIMARY TRANSLATIONAL RESEARCH OBJECTIVES:

I. To test the hypothesis that purified protein derivative (PPD) test conversion (positive PPD at 3 or 6 months) following BCG immunotherapy will predict time to high-grade recurrence (TTHGR).

II. To test the hypothesis that urinary cytokine levels measured prior to weeks 1, 3 and 6 BCG instillation will predict time to high-grade recurrence (TTHGR).

III. To test the hypothesis that tumor neoantigen burden and T-lymphocyte infiltration are associated with BCG response.

IV. To assess whether changes in pre-BCG extracellular vesicle profiles in urine and blood from week 1 to week 3 vary by treatment arm and whether these changes are prognostic for TTHGR.

PATIENT REPORTED OUTCOMES OBJECTIVES:

I. To compare the change (baseline to 6 month) in patient-reported bladder cancer-specific quality of life between TICE and Tokyo BCG strains.

II. To compare the change (baseline to 6 month) in patient-reported quality of life between priming and no priming.

III. To test the hypothesis that changes in urinary symptoms during BCG treatment predict time to high-grade recurrence (TTHGR).

IV. To evaluate whether smoking status is associated with time TTHGR, and whether the efficacy of BCG strain (Tice versus [vs.] Tokyo) and BCG priming is modified by measures of smoking exposure.

V. To estimate adverse event profiles for each of the three treatment arms by smoking status.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I:

INDUCTION: Patients receive BCG solution intravesically once a week for 6 weeks.

MAINTENANCE: Patients receive BCG solution intravesically once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for 21 doses.

ARM II:

INDUCTION: Patients receive BCG Tokyo-172 strain solution intravesically once a week for 6 weeks.

MAINTENANCE: Patients receive BCG Tokyo-172 strain solution intravesically once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for 21 doses.

ARM III:

PRIME: Patients receive BCG Tokyo-172 strain vaccine once intradermally (ID).

INDUCTION: Within 21 days, patients receive BCG Tokyo-172 strain solution as in Arm II.

MAINTENANCE: Patients receive BCG Tokyo-172 strain solution as in Arm II.

After completion of study treatment, patients are followed up for 5 years.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
SWOG

Principal Investigator
Robert Scott Svatek

  • Primary ID S1602
  • Secondary IDs NCI-2016-00451
  • Clinicaltrials.gov ID NCT03091660